Trametinib product-specific bioequivalence guideline - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of trametinib.

Keywords: Bioequivalence, generics, trametinib

Current version

Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/41624/2023 Legal effective date: 01/06/2025

English (EN) (126.39 KB - PDF)

First published: 19/12/2024

Overview of comments received on Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Reference Number: EMA/339228/2024

English (EN) (332.94 KB - PDF)

First published: 19/12/2024

Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 11/03/2024 to 30/06/2024 Reference Number: EMA/CHMP/41624/2023 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (136.78 KB - PDF)

First published: 11/03/2024